MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number L5C4531

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that thirty (30) homechoice cassettes were damaged.The home patient (hp) stated that they noticed that the patient line on those cassettes had "two rings near where they connect to their catheter, it looked like a razor cut from the inside".The issue occurred during set up.There was no patient injury or medical intervention associated with this event.No additional information was available.

Manufacturer Narrative

Twenty-five (25) actual samples were received for evaluation.A visual inspection noted shallow scratches/cuts (not penetrating the tubing wall) affecting all the devices on the patient line tubing near the patient connector.The reported condition was verified.The cause of the condition was manufacturing related.Five (5) devices were not received for evaluation; therefore, a device analysis could not be completed on those samples.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7934986
• MDR Text Key: 122859405
• Report Number: 1416980-2018-06340
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/25/2023
• Device Catalogue Number: L5C4531
• Device Lot Number: H18F25038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2018
• Initial Date FDA Received: 10/04/2018
• Supplement Dates Manufacturer Received: 10/26/2018
• Supplement Dates FDA Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR